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Natural History Study of Azathioprine Adherence

Measurement of Compliance in Renal Transplant Recipients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00143910
Enrollment
180
Registered
2005-09-02
Start date
1993-04-30
Completion date
1999-10-31
Last updated
2023-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant

Keywords

Medication adherence, Patient compliance, Kidney transplant, Organ rejection, Allograft loss, Drug monitoring

Brief summary

This study began in 1993 as a prospective, natural history study of renal transplant patients' medication compliance measured by using an electronic monitor on the cap of medication vials. Hypothesis: Poor medication compliance predicts adverse outcomes. Enrollment is closed.

Detailed description

* The study is complete. Patient recruitment is closed and active patient involvement in the study has ended. * Statistical analysis of monitor records and new patient outcome data continues

Interventions

OTHERobservation

Sponsors

Thomas E. Nivens, MD
Lead SponsorINDIV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Kidney transplant recipient * Discharged from hospital with functioning graft,not on dialysis * Prescribed azathioprine

Exclusion criteria

* Unable to give informed consent * Non English speaking * Previous or concurrent organ transplant other than kidney * Taking liquid form of azathioprine * Followed outside of the United states

Design outcomes

Primary

MeasureTime frame
acute transplant rejection10 years

Secondary

MeasureTime frame
Allograft loss10 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026